Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT07237659
Eligibility Criteria:
1. Healthy males and females between 18 and 55 years of age.
2. Body mass index between 17.0 and 30.0 kg/m2.
3. Healthy with no clinically significant findings, as determined by medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations) at Screening Visit.
4. Participant voluntarily agrees to participate in this study and signs an Ethics Committee (EC) approved informed consent form (ICF) prior to performing any of the Screening Visit procedures.
5. Participant can understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
Exclusion Criteria:
1. Pregnancy, nursing, and/or breastfeeding.
2. The participant has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of the study intervention.
2\. Has received any prescription or nonprescription over the counter (except occasional use of acetaminophen, paracetamol, or ibuprofen prior to dosing) medication during the last 14 days. Occasional use is defined at the Investigator's discretion.
3\. Has a positive urine test for drugs of abuse, or cotinine at the Screening Visit, regular consumption of alcohol within 6 months before screening or use of illicit substances within 3 months before the Screening Visit.
4\. Has a positive test for hepatitis B surface antigen, hepatitis C virus and/or human immunodeficiency virus (HIV).
5\. Donation or loss of blood or plasma within 4 weeks before initial dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07237659
Study Brief:
Protocol Section:
NCT07237659